An interventional study of Health literacy intervention in Colorectal Cancer Screening, sponsored by University Paul Sabatier of Toulouse. Active, not recruiting at 4 sites in France. Open to participants aged 50 Years to 74 Years. Per ClinicalTrials.gov, last updated 2025-04-02.
Sponsored by University Paul Sabatier of Toulouse · Not applicable, Interventional, and Prevention
The aim of this project is to assess the impact of a health literacy (HL) intervention combining HL and CRC screening training for general practitioners with a short brochure and video targeting eligible patients to increase CRC screening and other secondary outcomes in four underserved geographic areas in France. The investigators will use a two-arm randomized controlled cluster trial at 8 clusters (2 per area) primarily serving underserved populations across 4 geographic areas in France with 32 primary care physicians and 1024 patients recruited.
Background Colorectal cancer (CRC) is a leading cause of cancer burden worldwide and the third most commonly diagnosed cancer in France (with 44,000 new cases in France each year). Systematic uptake of CRC screening can improve survival rates. However, people with limited health literacy (HL) and lower socioeconomic position rarely participate. The overall goal is to assess the impact of a HL intervention combining HL and CRC screening training for general practitioners with a short brochure and video targeting eligible patients to increase CRC screening and other secondary outcomes in four underserved geographic areas in France.
Methods The investigators will use a two-arm randomized controlled cluster trial at 8 clusters (2 per area) primarily serving underserved populations across 4 geographic areas in France with 32 primary care physicians and 1024 patients recruited. Primary care physicians practicing in underserved areas (identified using the European Deprivation Index and French Deprivation index) will be block-randomized to: 1) a combined intervention (HL and colorectal cancer training + brochure and video for eligible patients) or 2) usual care. The investigators will include all people between 50 and 74 years old who are eligible for CRC screening. The project will follow a community-based participatory research approach. The primary outcome is CRC screening uptake. The project will also include a qualitative needs assessment (focus groups and interviews) prior to finalizing the intervention and to test the acceptability of the combined intervention before the trial. After completing recruitment, semi-structured interviews will be conducted with up to 8 health professionals in each region (up to 24) and 6 to 12 patients per region (up to 48) based on data saturation. The investigators will explore strategies that promote the intervention's sustained use and rapid implementation using the Normalization Process Theory. A regression framework and mediation analyses will be used.
Discussion Limited HL and its impact on the general population is a growing public health and policy challenge worldwide. It has received limited attention in France. A combined HL intervention could reduce disparities in CRC screening, increase screening rates among most vulnerable populations, and increase knowledge and activation (beneficial in the context of repeat screening).
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
This study's enrollment of 1,025 is above the median of 76 across 4,800 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →University Paul Sabatier of Toulouse is the lead sponsor of 13 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
- People whose mental health status does preclude participation in the study, as determined by the participating primary care practitioner or their qualified staff.
Usual care in participating primary care practices.
Health literacy intervention combining health literacy and colorectal cancer screening training for general practitioners with a short brochure and video targeting eligible patients.
Behavioral: Health literacy intervention
We will translate and adapt an intervention developed by Ferreira et al. to address health literacy and improve CRC screening. This intervention combined a 2-hour health literacy training targeting primary care physicians (which also included information about CRC screening) and a patient level intervention that consisted of a brochure and video. In order to promote generalizability, large-scale diffusion, dissemination and sustained use beyond the funded-research period, we will use blended learning to develop a 2-hour e-learning health literacy training in French and a one-hour booster session. The patient-facing intervention (video + brochure) will follow key plain language and health literacy principles to translate evidence-based information in content that all patients can understand. Existing materials developed in France will be used and adapted as relevant.
Colorectal cancer screening uptake
This information will be collected by each regional screening coordination center of the four participating regions, in collaboration with the health insurance (CPAM) at 6 months (for feedback to general practitioners in the intervention arm) and 1-year post enrollment into the study. It will also be collected using self-report in the patient questionnaire 1-year post enrollment.
Time frame: up to 1-year post enrollment
Plan to share: No
This study is active, not recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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University Paul Sabatier of Toulouse